1.1 本规程规定了标准物质（RM）生产商必须证明其操作的一般要求，前提是其被认为有能力生产用于水分析的RMs。 1.2 本规程建立了质量体系要求，根据该要求生产waters RMs。它旨在作为RM生产商一般质量保证（QA）程序的一部分。RM生产商应根据应用、均匀性、稳定性和表征研究中使用的测量方法确定其范围。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本规程供RM生产商在制定和实施其质量体系时使用，也供与评估RM生产商能力相关的人员使用。应认识到，RM的特征主要需要达到其预期目的所需的精度水平（即适当的测量不确定度）。RM生产商应描述将材料质量作为质量体系组成部分的程序。 4.2 如果RM生产商具有足以生产高质量RM的质量体系，则本实践适用于RM用户在企业中的使用。用户可以使用它来确定RMs生产商的科学和技术能力是否足以确保RMs的质量。该做法符合ISO指南34中对RM生产商的要求。 4.3 本规程未规定RMs分析证书内容、分析化学校准和认证RMs使用以及RMs认证的具体协议。有关此信息，请参考实践 D6362 、ISO指南32和ISO指南35。

1.1 This practice establishes the general requirements with which a reference materials (RM) producer has to demonstrate that it operates, if it is to be recognized as competent to produce RMs used for water analysis. 1.2 This practice establishes the quality system requirements in accordance with which waters RMs shall be produced. It is intended to be used as part of a RM producer’s general quality assurance (QA) procedures. RM producers shall define their scope in terms of the application, the measurement methods used in the homogeneity, stability, and characterization studies. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This practice is for the use by RM producers in the development and implementation of their quality system and by those concerned with assessing the competence of RM producers. It should be recognized that a RM needs to be characterized mainly to the level of accuracy required for its intended purpose (that is, appropriate measurement uncertainty). The RM producer shall describe the procedure for establishing the quality of materials as a component of the quality system. 4.2 This practice is for the use of RM users in the establishment if a RM producer has a quality system adequate to produce high quality RMs. It can be used by users to determine if the scientific and technical competence of a RMs producer is adequate to ensure the quality of RMs. This practice is consistent with the requirements for RM producers established in ISO Guide 34. 4.3 This practice does not specify specific protocols for the contents of RMs certificates of analysis, for calibration in analytical chemistry and use of certified RMs and for certification of RMs. For this information, users are referred to Practice D6362 , ISO Guide 32, and ISO Guide 35.